Depression in type 2 diabetes MedDRA version: 20.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Januvia (Sitagliptin)
Product Name: Januvia (Sitagliptin)
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, ha
Sponsors
King's College London
Kings College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of type 2 diabetes according to GP records or clinical guidelines for minimum 6 months 2. Aged 18-75 3. Poor glycaemic control defined as HbA1c 53-86 mmol/mol 4. Already prescribed a first-line anti-diabetes agent (metformin or sulphonylurea) for at least 3 months 5. Current PHQ-9 score =10 6. Fluent in conversational English 7. Able to sign informed consent form 8. Use of contraception if female and of childbearing age. Female participants will require a negative serum pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. oral contraceptive pill, long-acting reversible contraceptive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: 1. Advanced diabetes complications (registered blind, on dialysis, previous above-knee amputation) or treatment with insulin 2. Pregnancy (tested with serum pregnancy test), planning pregnancy or lactating 3. Severe mental disorders (psychosis, dementia, learning disability, alcohol/substance dependence, active suicidal ideation) 4. Non diabetes-related inflammatory condition or history of pancreatitis 5. Estimated Glomerular Filtration Rate 40kg/m2) 7. HbA1c >86 mmol/mol 8. Currently prescribed an incretin-based therapy (dipeptidyl peptidase-IV inhibitor or GLP-1 receptor agonist) 9. Currently prescribed an anti-depressant tablet or in receipt of psychological therapy for depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate whether blood sugar control and reduce systemic inflammation are reduced in patients with type 2 diabetes;Primary end point(s): Primary: change in depressive symptoms after 12 weeks as measured by the Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16).;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To investigate whether depressive symptoms improve in patients with type 2 diabetes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in depressive symptoms after 4- and 8 weeks (mid-treatment) and 24 weeks (post-treatment) as measured by Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16). -Change in glycaemic control (fasting glucose, insulin resistance [homeostasis model assessment]), and inflammatory markers (interleukin-4 [IL-4], IL-6, IL-10, C-reactive protein, tumour necrosis factor-a, IL-1ß, IL-1RA, vascular endothelial growth factor, monocyte chemotactic protein-1, white cell count and fasting triglycerides) after 4-, 8- and 12 weeks. -Change in HbA1c from baseline to 12 weeks. ;Timepoint(s) of evaluation of this end point: 4-, 8-, 12-, and 24 weeks after commencement of treatment | — |
Countries
United Kingdom
Contacts
Public ContactProf Khalida Ismail
King's College London
Outcome results
None listed